FDA Approves Three Generic Versions of Novartis’ Gilenya for Treating Relapsing MS

The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS).

A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the FDA have been licensed to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release.

“Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines,” Woodcock said.

Developed by Novartis, Gilenya was the first oral disease-modifying therapy (DMT) to be approved by the FDA and the European Commission (EC) for the treatment of adults and children with relapsing-remitting multiple sclerosis (RRMS), age 10 and older.

The medication works by preventing immune cells from reaching the brain and spinal cord, reducing inflammation, disease progression, and the risk of MS relapses.

Gilenya does that by binding to a protein found on the surface of immune cells called sphingosine 1-phosphate (S1P) receptor, which prevents those cells from responding to signals that lead them to migrate from lymph nodes — the place where the cells are produced and stored — to other parts of the body.

The most common side effects associated with Gilenya treatment reported in clinical trials include headache, high levels of liver enzymes (indicative of liver inflammation), diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.

The newly approved fingolimod capsule generics must be dispensed with a Medication Guide that discloses important information regarding their use and associated risks.

Fingolimod may cause vision problems, slow the heart rate (especially after the first dose), increase the risk of serious infections, and increase the risk of progressive multifocal leukoencephalopathy (PML), which is a rare brain infection that may lead to severe disabilities or be fatal. For that reason, it is recommended that patients should be monitored closely for any signs of infections during treatment, and for two months after discontinuing therapy.

Fingolimod also may increase the risk of respiratory problems, liver damage, high blood pressure, and skin cancer. In addition, because the medication may be harmful to a developing fetus, physicians should disclose this risk to women of child-bearing age, and encourage the use of effective contraception methods.